OmniPod UST400 User manual

Model: UST400

Contacts and Important Information

o

Name

Address

Telephone and Fax

Email Address

Name

Address

Telephone and Fax

Email Address

Name

Address

Telephone Number(s)

Policy Number

Name

Address

Telephone and Fax

Email Address

OmniPod System Start Date: ____________________________

PDM Model UST400 Serial Number: _____________________

Emergency Services:

Dial 911 (USA only; not available in all communities)

Insulet Corporation

9 Oak Park Drive, Bedford, MA 01730

Customer Care (24 hours/7 days): 800-591-3455

When calling from outside the United States: 781-457-5098

Customer Care Fax: 877-467-8538

Web site: MyOmniPod.com

Doctor

Nurse/Educator

Health Insurance

Pharmacy

Use the spaces below to record important health and product information.

OmniPod is a registered trademark of Insulet Corporation.

U.S. Patent No. 6,740,059.

FreeStyle is a registered trademark of Abbott Laboratories.

Third-party trademarks used herein are the trademarks of their respective owners.

14421-AW Rev C

iii

Contents

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii

About This User Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii

Conventions and Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix

Important Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix

Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Your Role: Safely Using the OmniPod System . . . . . . . . . . . . . . . . . . . xi

1 Your New OmniPod Insulin Management System . . . . . . . . . . 1

Insulin Delivery with the OmniPod System. . . . . . . . . . . . . . . . . . . . . . 1

How Does the OmniPod System Work? . . . . . . . . . . . . . . . . . . . . . . . . . 2

No tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Suggested bolus calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Reference food library and carb presets . . . . . . . . . . . . . . . . . . . . . . 2

A fully-integrated design with blood glucose monitoring . . . . 3

Record keeping. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Personalizing your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

The Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

The Personal Diabetes Manager. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Buttons that program and control the OmniPod System . . . . . 5

Primary screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Safety Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Automatic priming, safety checks, and insertion . . . . . . . . . . . . . 8

Occlusion detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Alerts and alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

The OmniPod Starter Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Set Up the Personal Diabetes Manager (PDM). . . . . . . . . . . . . . . . . . . 9

The Setup Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Enter your PDM ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Select the ID screen color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Set date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Enter basal settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Enter blood glucose sound setting and BG goal. . . . . . . . . . . . . 13

Enter target blood glucose value. . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Enter minimum BG allowed for use in bolus calculation. . . . . 14

Enter insulin-to-carbohydrate ratio. . . . . . . . . . . . . . . . . . . . . . . . . . 14

Enter correction factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Set reverse correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Enter the duration of insulin action. . . . . . . . . . . . . . . . . . . . . . . . . . 15

Select bolus increment and enter maximum bolus. . . . . . . . . . 15

Set extended bolus doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Set low reservoir advisory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Set Pod expiration notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

3 Understanding and Adjusting Basal Rates . . . . . . . . . . . . . . . . 17

What Is a Basal Rate? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Contents

iv

Personalized Basal Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Create a basal program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Enable an existing basal program . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Change, rename, copy, or delete a basal program . . . . . . . . . . . 21

Temporary Basal Rates and Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

What is a temporary basal rate? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Enable a one-time temporary basal rate. . . . . . . . . . . . . . . . . . . . . 24

Cancel a one-time temporary basal rate . . . . . . . . . . . . . . . . . . . . . 25

Create a temporary basal preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Enable an existing temporary basal preset . . . . . . . . . . . . . . . . . . 26

Cancel an active temporary basal preset . . . . . . . . . . . . . . . . . . . . 27

Change, rename, or delete a temporary basal preset . . . . . . . . 27

Maximum Basal Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

What is the maximum basal rate?. . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Change the maximum basal rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

4 Understanding and Delivering Bolus Doses. . . . . . . . . . . . . . . 29

What Is a Bolus? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Bolus Dose Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Suggested Bolus Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

How a suggested bolus is calculated . . . . . . . . . . . . . . . . . . . . . . . . 31

Deliver a Normal Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Deliver a bolus when suggested bolus calculator is On. . . . . . 32

Deliver a bolus manually (suggested bolus calc is Off). . . . . . . 34

Deliver an Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Deliver an extended bolus instead of a normal bolus. . . . . . . . 35

Cancel Active Boluses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Replace an Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Bolus Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Create a bolus preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Enable an existing bolus preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Change, rename, or delete a bolus preset . . . . . . . . . . . . . . . . . . . 39

Cancel an active bolus preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Carb Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Create a carb preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Change or edit a carb preset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Delete a carb preset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Reference Food Library. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Access the reference food library . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

5 Using the Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

The Pod Change Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Gather equipment and supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Deactivate the current Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Fill a new Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Select the infusion site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Prepare the infusion site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Apply the new Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Insert cannula and begin insulin delivery. . . . . . . . . . . . . . . . . . . . 54

Check Pod Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Suspend Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Resume Insulin Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Avoid Infusion Site Infections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Get the Most From Your Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Avoid extreme temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Water and your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Safe storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Contents

v

6 Using the Personal Diabetes Manager . . . . . . . . . . . . . . . . . . . . 61

The ID Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

The Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Insulin gauge and display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

PDM settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

The System Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Reset the Date or Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Reset the time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Reset the date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Change Bolus and Basal Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Bolus calcs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Ratios/factors/targets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Temp basal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Extended. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Bolus increment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Max bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Max basal rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Alerts and Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Set alerts and reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Change Blood Glucose Meter Settings . . . . . . . . . . . . . . . . . . . . . . . . . 72

Change BG goal limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Manage the blood glucose tags list . . . . . . . . . . . . . . . . . . . . . . . . . 72

Change BG sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Customize the Personal Diabetes Manager . . . . . . . . . . . . . . . . . . . . 73

Set PDM options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Set ID screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Set PDM lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Set the Screen time-out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Set the Backlight time-out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Set Diagnostic Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Diagnostic options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Set a Reminder to Vibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Get the Most from Your PDM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Keep it handy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Communicating with the Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Water and your PDM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Avoid extreme temperatures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Electrical interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

7 Checking Your Blood Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

The Built-in FreeStyle® Blood Glucose Meter . . . . . . . . . . . . . . . . . . . 79

The FreeStyle® Blood Glucose Test Strips . . . . . . . . . . . . . . . . . . . . . . . 80

Important test strip information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

The FreeStyle® Control Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

When to perform a control solution test. . . . . . . . . . . . . . . . . . . . . 81

Check that the meter and test strips are working. . . . . . . . . . . . 81

Control solution expiration date. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Ensure accurate control solution results . . . . . . . . . . . . . . . . . . . . . 81

Performing a Control Solution Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Performing a Blood Glucose Reading . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Prepare the lancing device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Insert the blood glucose test strip . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Set the blood glucose test strip code. . . . . . . . . . . . . . . . . . . . . . . . 88

Lance your upper arm or hand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

Fill the blood glucose test strip with blood . . . . . . . . . . . . . . . . . . 90

Remove the lancet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Contents

vi

Blood Glucose Results and the Suggested Bolus

Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Entering Blood Glucose Readings Manually . . . . . . . . . . . . . . . . . . . . 93

Editing Tags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Low and High Blood Glucose Readings. . . . . . . . . . . . . . . . . . . . . . . . . 95

Low readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

High readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

Important Health-Related Information . . . . . . . . . . . . . . . . . . . . . . . . . 96

8 Understanding Your Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

Special symbols in record screens . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

Insulin Delivery Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

View insulin delivery records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Blood Glucose Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

View single-day trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

View multiple-day trends. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

Alarm Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Carbohydrate Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

All Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

User Information/Support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Add or change user information. . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

9 Living with Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Your Role: Safely Using the OmniPod System. . . . . . . . . . . . . . . . . . 106

Daily Diabetes Management Activities . . . . . . . . . . . . . . . . . . . . . . . . 106

Check your blood glucose frequently. . . . . . . . . . . . . . . . . . . . . . . 107

Inspect the infusion site daily. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Prepare for Emergencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

Water and Your Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

Traveling and Vacationing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Plan for changing time zones. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Take enough supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Minimize airport security delays . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Keep supplies accessible . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

Avoid lows, highs, and DKA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

General precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Hypoglycemia (Low Blood Glucose) . . . . . . . . . . . . . . . . . . . . . . . . 111

To avoid hypoglycemia (low blood glucose). . . . . . . . . . . . . . . . 112

To treat hypoglycemia (low blood glucose). . . . . . . . . . . . . . . . . 112

Hyperglycemia (high blood glucose) . . . . . . . . . . . . . . . . . . . . . . . 115

Diabetic ketoacidosis (DKA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

Handling Special Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Sick days. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Exercising, playing sports, or working hard . . . . . . . . . . . . . . . . . 120

X-rays, MRIs, and CT scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

Surgery or hospitalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

10 Alerts and Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Blood Glucose Meter Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Advisory Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Hazard Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Manual Shut-off of a Hazard Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

11 Communication Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

The Communication Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

Contents

vii

Failure During Pod Activation or Operation . . . . . . . . . . . . . . . . . . . 132

Failure During Pod Deactivation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Failure During Request for Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Failure During Bolus Cancellation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Pod Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Personal Diabetes Manager Care and Maintenance . . . . . . . . . . . 138

Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Cleaning and disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Replacing Batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

If the PDM becomes submerged in water . . . . . . . . . . . . . . . . . . 141

If you drop the PDM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Storage and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Suggested Bolus Calculator Examples and Guidelines . . . . . . . . 143

Meal bolus calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Insulin-on-board (IOB) calculation. . . . . . . . . . . . . . . . . . . . . . . . . . 143

Calculator guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

OmniPod System Options and Settings . . . . . . . . . . . . . . . . . . . . . . . 147

Pod Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Accuracy Test Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Flow rate error. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Personal Diabetes Manager Specifications . . . . . . . . . . . . . . . . . . . . 150

Blood Glucose Meter Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

OmniPod System Label Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

Personal Diabetes Manager Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

OmniPod System Notice Concerning Interference . . . . . . . . . . . . 152

Electromagnetic Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

Customer Bill of Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Mission Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Scope of Services. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Supply Shipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Inquiries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

CHAP Accredited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Customer’s Bill of Rights and Responsibilities. . . . . . . . . . . . . . . 158

Limited Warranty for the Personal Diabetes Manager . . . . . . . . . 159

HIPAA Privacy Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

Uses and Disclosures of Medical Information. . . . . . . . . . . . . . . 160

Your Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Our Duties. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

What To Do If You Have a Problem or Question. . . . . . . . . . . . . 163

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170

viii

n About This User Guide

Symbols

Symbol Term Meaning

Warning Describes potential serious adverse

reactions, or indicates conditions that

could cause death or serious injury.

Caution Caution: Consult accompanying doc-

uments.

Note Provides helpful information.

Tip Offers a suggestion for successful use

of the OmniPod® Insulin Manage-

ment System.

This User Guide is intended for use only with PDM

model UST400. To learn which version of the PDM

you have, turn it over. On the back of the PDM, look

for “UST400.” If you see it, this is the correct User

Guide. If you do not see “UST400” on the back of the

PDM, please call Customer Care.

This User Guide is periodically updated. Visit the Cus-

tomer Care section of MyOmniPod.com to see the

most recent version and to find other helpful infor-

mation.

Users should wash hands thoroughly with soap and

water after handling the meter, lancing device, or test

strips.

Reminder: Users should activate the PDM periodically to

confirm that there are no alerts or alarms that require a

response.

Introduction

ix

Conventions and Terms

Important Information

Indication

The OmniPod® Insulin Management System is intended for sub-

cutaneous (below the skin) delivery of insulin at set and variable

rates for the management of diabetes mellitus in persons requir-

ing insulin and for the quantitative measurement of glucose in

fresh whole capillary blood (in vitro) from the finger.

The glucose measurements should not be used for the diagnosis

of or screening for diabetes. The PDM glucose meter is intended

for single-patient use and should not be shared.

Screen displays shown in this User Guide are for illustrative

purposes only and should not be considered suggestions

for user settings. Consult with your healthcare provider to

determine the appropriate settings for you.

Convention/Term Meaning

Bold Names of buttons, soft keys, menus, and

screens are in bold.

Italics Words in italics are defined in the

Glossary at the end of this User Guide.

Press Press and release a button or soft key.

Hold Keep pressing a button until its function is

complete.

Menu A list of options on the PDM. Options allow

you to perform tasks.

Screen Displays programming, operating, and

alarm/alert information.

Button A physical button on the PDM, such as the

Home/Power button.

Convention/Term Meaning

Icon An image on the PDM screen that indi-

cates a menu option or item of informa-

tion. A table of screen icons appears in the

Appendices.

Soft keys A row of three unlabeled buttons on the

PDM whose label or function appears on

the screen directly above the button. The

label changes depending on the task you

are performing.

US Federal law restricts this device to sale by or on

the order of a physician.

Introduction

x

Abbott FreeStyle® test strips are used with the built-in FreeStyle

meter for the quantitative measurement of blood glucose in

fresh whole capillary blood from the finger, upper arm and palm.

Abbott FreeStyle Control Solutions are used to verify that the

meter and test strips are working together properly and that the

test is performed correctly.

Contraindications

Insulin pump therapy is NOT recommended for people who are

either:

• Unable to perform at least four (4) blood glucose tests per day

• Unable to maintain contact with their healthcare provider

• Unable to use the System according to instructions

Do not use the integrated FreeStyle Blood Glucose Monitoring

System for:

• Testing on newborns

• Testing arterial blood

• Diagnosing of or screening for diabetes mellitus

The OmniPod System should NOT be used in a

hyperbaric chamber as there is a potential for an

explosion. There are active electronics inside the Pod

and PDM, and a hyperbaric chamber has high con-

centrations of oxygen.

The OmniPod System is designed to use rapid-act-

ing U-100 insulin. The following U-100 rapid-acting

insulin analogs have been tested and found to be

safe for use in the Pod: Novolog®/NovoRapid®,

Humalog®, or Apidra®. Novolog® is compatible with

the OmniPod System for use up to 72 hours (3 days).

Before using a different insulin with the OmniPod

System, check the insulin drug label to make sure it

can be used with a pump. Refer to the insulin label-

ing and follow your healthcare provider’s directions

for how often to replace the Pod.

Not recommended for individuals with hearing

loss. Always verify ability to hear Pod/PDM alerts

and alarms.

The Pod and PDM may be affected by strong radi-

ation or magnetic fields. Before having an X-ray, MRI,

or CT scan (or any similar test or procedure), remove

your Pod and put it and the PDM outside the treat-

ment area. Check with your healthcare provider for

Pod removal guidelines.

Introduction

xi

The glucose meter and lancing device are for single-

patient use. Do not share the device with anyone

including other family members. Do not use on mul-

tiple patients.

Parts of the device are considered biohazardous and

can potentially transmit infectious diseases, even

after you have performed cleaning and disinfection.

If you are unable to use the System according to

instructions, you may be putting your health and

safety at risk. Talk with your healthcare provider if

you have questions or concerns about using the

System properly.

Please read all the instructions provided in this User

Guide and practice the blood glucose testing proce-

dures before using the System. Monitor your blood

glucose with the guidance of your healthcare pro-

vider. Undetected hyperglycemia or hypoglycemia

can result without proper monitoring.

This device is intended for self-testing by the user.

If you are having symptoms that are not consistent

with your blood glucose test and you have followed

all instructions described in this User Guide, call your

healthcare professional.

n Your Role: Safely Using the OmniPod System

Pump therapy requires substantial caregiver involvement,

especially among children. Work with your healthcare provider

to establish diabetes management guidelines and settings that

best fit your, or your child’s, needs. These may include:

Insulin-to-Carbohydrate (IC) Ratio: Number of grams of car-

bohydrate covered by one unit of insulin. For example, if your

insulin-to-carbohydrate ratio is 1:15, then you need to deliver

one unit of insulin to cover every fifteen grams of carbohydrate

you eat.

Correction or Sensitivity Factor: How much one unit of insulin

will lower blood glucose. For example, if your sensitivity factor is

50, one unit of insulin will lower your blood glucose by 50 mg/

dL.

Target Blood Glucose Value: The blood glucose level you want

to achieve. For example, you may want to keep your blood glu-

cose close to 100 mg/dL.

Duration of Insulin Action: The length of time that insulin

remains active and available in your body after a correction or

meal bolus.

Introduction

xii

Your individual needs influence the initial settings you and your

healthcare provider will enter into the Personal Diabetes Man-

ager (PDM) during setup (see Chapter 2, Getting Started).

Your healthcare provider must help you enter these initial set-

tings. Soon you will enter and change your own settings with

confidence and ease. The OmniPod System is more user-friendly

than most electronic devices you use every day. In fact, technol-

ogy is what makes the OmniPod System so easy to use.

Your healthcare provider is a valuable resource. You will rely on

him or her for a lot of critical information about your OmniPod

System, especially during the first few weeks and months. When

you have questions about diabetes management after starting

on the OmniPod System, do not hesitate to talk with your health-

care provider. For nonmedical emergencies or for technical

questions about your OmniPod System setup or operation, you

can call Customer Care 24 hours a day, 7 days a week.

Customer Care (24 hours/7 days): 800-591-3455

When calling from outside the United States: 781-457-5098

Customer Care Fax: 877-467-8538

Web site: MyOmniPod.com

Your healthcare provider will give you all the tools and training

you need to be successful with the OmniPod Insulin Manage-

ment System. However, in the end, your success depends on

YOU. You must become actively involved in your own diabetes

management to enjoy the outstanding control, freedom, and

flexibility that is possible with the OmniPod System.

Being actively involved means:

• Frequently monitoring blood glucose levels

• Learning how to operate your OmniPod System and practic-

ing proper techniques

• Visiting your healthcare provider

Do NOT attempt to use the OmniPod® Insulin Man-

agement System before you receive training from

your healthcare provider. Inadequate training could

put your health and safety at risk

1

CHAPTER 1

Your New OmniPod Insulin Management System

n Insulin Delivery with the OmniPod System

The OmniPod® Insulin Management System is an innovative

continuous insulin delivery system that provides all the proven

benefits of continuous subcutaneous insulin infusion (CSII) therapy

in a way no conventional insulin pump can. The System’s innova-

tive design and features allows you to live your life—and

manage your diabetes—with unprecedented freedom, comfort,

convenience, and ease.

The long-term health benefits of better blood glucose control

are well known. Maintaining near-normal blood glucose levels

can help you live a longer, healthier life with fewer diabetes-

related complications. The OmniPod System also has many prac-

tical, everyday benefits, including convenience, freedom,

flexibility, and ease of use.

Continuous insulin delivery most closely mimics the insulin

release of a healthy pancreas. Since the landmark 10-year

Diabetes Control and Complications Trial (DCCT), the long-

term health benefits of maintaining near-normal blood

glucose levels have been widely recognized.

Continuous insulin delivery at preset rates eliminates the need

for injections and the interruptions that come with them. In addi-

tion, with the OmniPod System, insulin delivery can be changed

with the press of a button to adapt to snacks or unexpected

changes in daily routine. The OmniPod System is a great option

for people with diabetes who require insulin.

The OmniPod System works much like the pancreas of a person

without diabetes by delivering insulin in two ways:

• A small, constant, background supply of insulin (called a basal

rate) is delivered automatically at a programmed rate, all day

and night.

• An extra dose of insulin (called a bolus) can be delivered

when you need it to match the carbohydrates in a meal or

snack or to correct a high blood glucose.

Your New OmniPod Insulin Management System

2

1

n How Does the OmniPod System Work?

The Pod is a small, lightweight, self-adhesive device that you fill

with insulin and wear directly on your body. The Pod delivers

precise, personalized doses of insulin into your body through a

small flexible tube (called a cannula), based on instructions that

you program into its wireless companion, the Personal Diabetes

Manager. The cannula is inserted only once with each Pod.

The Personal Diabetes Manager (PDM) is a wireless, handheld

device that:

• Programs the Pod with your personalized insulin-delivery

instructions

• Wirelessly monitors the Pod’s operation

• Includes a FreeStyle® blood glucose meter

With just two parts, you’ll enjoy all the functionality and benefits

of continuous insulin delivery and blood glucose monitoring.

Plus you’ll enjoy the safety, convenience, and freedom of:

No tubing

There is no tubing connecting the Pod to the PDM. You wear the

Pod comfortably and discreetly under your clothes. You can carry

the PDM separately in a backpack, briefcase, or purse. With the

OmniPod Insulin Management System, you don’t have to worry

about snagging, tangling, or feeling tethered by tubing.

Suggested bolus calculation

Calculating bolus doses has never been easier. After you check

your blood glucose, enter the carbs for your snack or meal. Based

on your individual settings, the System displays a suggested

bolus dose. You can accept the suggestion, change it, or cancel it.

Reference food library and carb presets

To make carbohydrate counting easier, the OmniPod System

includes a reference food library. You can look up the carbs and

other values for many standard food items. Foods are organized

alphabetically and by category.

Your New OmniPod Insulin Management System

3

1

You can also enter your own favorite foods, snacks, or entire

meals as “carb presets.” Presets contain the grams of carbohy-

drate in the food item or meal. Next time you eat this same food,

you don’t have to count the carbs; just select your carb preset

and the System does the calculating for you. The System stores

up to 36 carb presets.

Automated cannula insertion

With the OmniPod System, you don’t have to insert the infusion

set manually or carry around a separate inserter. You simply press

a button on the PDM and the Pod’s automated insertion system

safely and consistently inserts the cannula beneath the skin, vir-

tually pain free. It then begins delivering insulin according to

your programmed basal rate.

A fully-integrated design with blood glucose monitoring

With a fully integrated two-part design, there’s no need to carry

separate infusion sets, reservoirs, or inserters. It’s all integrated

into the Pod. With the PDM, you can check your blood glucose

level using FreeStyle® blood glucose test strips, but without the

hassle of carrying a separate blood glucose meter.

If you prefer to use another blood glucose meter, you can enter

the readings manually into the PDM.

Record keeping

Another convenient part of the OmniPod System is record keep-

ing. Paper charts are useful, but sometimes they can be

inconvenient to carry or use. The data storage system in the

Personal Diabetes Manager (PDM) displays up to 90 days’ worth

of information. This includes blood glucose readings, basal rates

and bolus doses, carbohydrates, and alarms.

Personalizing your System

You can personalize your OmniPod System in other ways, too:

• Enter and name basal programs

• Name and save temporary basal presets

• Add your own customized reminders

• Enter your name, phone number, doctor’s name and

number, and other emergency information

Your New OmniPod Insulin Management System

4

1

n The Pod

The Pod (Figure 1-1) is applied to your skin with an adhesive, sim-

ilar to an adhesive bandage.

n The Personal Diabetes Manager

All Pod operations are programmed and controlled through the

Personal Diabetes Manager (PDM; Figure 1-2).

Top

Bottom

Needle cap

Viewing window

Fill port

Figure 1-1

Adhesive

backing

Housing vent

Figure 1-2

Up/Down

Controller

User Info/

Support

Soft Key

Label

Soft Keys

Home/

Power

USB Port

Test Strip Port

LCD Screen

Your New OmniPod Insulin Management System

5

1

Buttons that program and control the OmniPod System

Button Action

Home/

Power Pressing and holding turns the PDM on and off.

When the PDM is on, pressing this button

(quickly/briefly) displays the Home screen, from

which you can choose a menu item or view the

Status screens (shown later in this chapter).

Up/Down

Controller Pressing and releasing scrolls through a list of

available menu options or numbers, so you can

pick the one you want. Holding the button

scrolls faster.

Soft Keys Soft key labels and functions depend on the

menu or screen you are viewing. The label

appears on the screen directly above the physi-

cal button you press. Select, Save, and Back are

just three examples of the soft key labels on your

PDM.

Button Action

User Info/

Support Pressing opens a User Info/Support screen that

displays additional information about the cur-

rent screen you are viewing. The User Info/Sup-

port icon appears when additional information

can be viewed. It may be displayed at the top of

the screen, to the right of an event detail (such as

a suggested bolus), or to the right of a record

item (such as a BG history record). (See “Personal

Diabetes Manager Icons” in the Appendix).

In addition, pressing and holding this button for

2 seconds enables a “bright mode” on the PDM

screen.

Your New OmniPod Insulin Management System

6

1

Primary screens

Messages on the screen either:

• Let you identify your PDM

• Tell you how the System is operating

• List menu choices

• Explain how to perform certain tasks

The System’s primary screens are the ID screen (Figure 1-3), the

Status screen (Figure 1-4), and the Home screen (Figure 1-6 on

the next page).

ID screen

The System displays an ID screen to make the PDM easy to

identify when you first turn it on. You can personalize the ID

screen by adding your name and choosing its color. (See , for

details on customizing your PDM.) You must acknowledge the

ID screen before you can use the PDM. It is important that you

always identify the PDM as yours before you use it.

Status screen

Lists the System’s current operating status (Figure 1-4).

From top to bottom, the Status screen displays:

• Current date and time

• Battery life remaining

• Insulin remaining

• Time, date, and result of last blood glucose checked or

entered manually

• Time, date, and total amount of last bolus delivered

• Amount of Insulin on Board (IOB) will be displayed on

Status screen (if calculator in use)

• Name and rate of active basal program or temp basal

program

• “Ext bolus,” the amount of insulin, and the delivery time

remaining if an extended bolus is being delivered

• “INSULIN SUSPENDED” if insulin delivery has been

suspended

• Time and date of when the Pod will expire

Figure 1-3 Figure 1-4

Your New OmniPod Insulin Management System

7

1

Status support screen

From the Status screen, press the User Info/Support button to

see details about the current insulin on board (IOB) in your

body (Figure 1-5). See page 31, for additional information

describing insulin on board (IOB).

Home screen

Lists all the major menus (Figure 1-6).

•Bolus menu to deliver bolus doses

•More actions menu to change the Pod, manually enter

blood glucose readings, and assign and edit tags for BG read-

ings that are less than 2 hours old.

•Temp basal menu to deliver temporary basal rates (This

submenu does not appear if temp basal is turned Off in

Settings.)

•My records menu to review insulin delivery, blood glucose

history, alarm history, carb history, and personal user informa-

tion

•Settings menu to edit, enter, and name basal programs,

temp basal, carbohydrate and bolus presets, and to custom-

ize System settings

•Suspend menu to suspend, cancel, or resume insulin

delivery programs

If a Pod has not yet been activated (during Pod changes),

the screen displays “No active Pod. Would you like to acti-

vate a Pod now?” (See Chapter 5, Using the Pod, for details

on activating a Pod.)

Figure 1-5 Figure 1-6

You can go to the Status screen at any time by

pressing Status from the Home screen.

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OmniPod UST400 User manual

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